Machine proximate nebulizer

ABSTRACT

Systems and methods for providing respiratory therapy are disclosed. The system includes a nebulizer operable to aerosolize a medicament, a cylindrical mixing chamber, an impacting cap and a recirculation tube. The mixing chamber has an inlet port, an outlet port, an aerosol port in fluid communication with the nebulizer, and a drainage port. The inlet port receives a flow of breathing gas. The mixing chamber receives the aerosol via the aerosol port, entrains aerosol into the flow of breathing gas, and delivers the breathing gas entrained with aerosol to the outlet port. The impacting cap receives and coalesces a portion of the aerosol into droplets within the space defined by the mixing chamber and the impacting cap. The mixing chamber is also configured to direct rain-out resulting from the droplets to the drainage port. The system also includes a recirculation tube to return the rain-out to the nebulizer.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. provisional application No.62/678,973, filed May 31, 2018, the contents of which are herebyincorporated herein by reference in their entirety.

BACKGROUND

Patients with respiratory ailments may be treated with respiratoryassist devices that deliver supplemental breathing gas to a patient. Insome instances, respiratory assist devices may be used for high flowtherapy (“HFT”). During HFT, a high flow rate of breathing gas(typically 8 liters per minute (lpm) or greater) is delivered to apatient via a nasal cannula to increase a patient's fraction of inspiredoxygen (“FiO2”), while simultaneously decreasing a patient's work ofbreathing. The breathing gas may be heated and humidified to reducepatient discomfort. Additionally, respiratory medications such asbronchodilators (e.g., Albuterol (Ventolin), Salbutamol (Proventil),Levosalbutamol/Levalbuterol (Xopenex)) for treating asthma or ChronicObstructive Pulmonary Disease (“COPD”) may also be administered throughinhalation directly to the patient's lungs. Nebulizers may be connectedto respiratory assist devices to supply the patient with the nebulizedmedication together with the supplemental breathing gas. Theserespiratory medications may be aerosolized by the nebulizer in order togenerate an aerosol of small particles of the medicament or drug, whichfacilitate distribution throughout the patient's lungs duringinhalation. Such systems can allow a patient to receive the medicationwithout stopping use of the respiratory assist device.

Delivering nebulized drug therapy though a nasal cannula poses severalsignificant challenges. The most significant problem is rain-out. Thisoccurs when the nebulized particles impact upon a surface and stick toit. During the course of drug therapy, the surface may be the innerwalls of the delivery device where the nebulized particles impact andcoalesce into larger droplets which are too large to be respirable. Thedelivery device may include a delivery tube and a patient interface(such as a nasal cannula, for example). The deliver tube provides aconduit through which the breathing gas and the nebulized particles areprovided to the patient from a source located away from the patient, andthe nasal cannula provides the breathing gas and the nebulized particlesfrom the delivery tube to the nares of the patient for inhalation.

When nebulized particles are contained in a flow of breathing gas, anychange in flow direction or turbulence can cause particles to impact asurface. This is exacerbated by high velocity flows encountered in HFTwhere the change in direction is more abrupt. In such situations, thegas is able to change direction, but the inertia of the particles causesthem to move toward the outside of any turn and impact the walls ofeither the delivery tube or nasal cannula. Nasal cannulas are inherentlysmall in cross section and therefore result in gases flowing throughthem at high velocity. Further, nasal cannulas have a number ofdirection changes incorporated into their configuration. Thus anynebulized particles that have not rained-out in the delivery tube mayimpact the inner walls of the nasal cannula thereby contributing furtherto rain-out. If the rain-out is sent to the patient, the large drops areclinically ineffective and irritating to the patient.

A high proportion of nebulized drugs rain-out in the delivery deviceduring therapy. As an example, by using a cannula manufactured byVapotherm, Inc. of Exeter, N.H., USA, during nebulizer based drugtherapy, approximately 75% of the nebulized drug will rain-out in thecannula. Sending a large quantity of drug, e.g. 10 mL/hr to 20 mL/hr,will therefore result in a corresponding large amount of rain-out, e.g.7.5 mL/hr to 15 mL/hr, at the cannula due to accumulation of rain-out inthe delivery tube and rain-out in the cannula. Large amounts of rain-outwill cause discomfort for the patient due to the buildup of condensedmedicament or drug in the cannula. Using a cannula manufactured byVapotherm, Inc. of Exeter, N.H., USA, for example, it has been shownthat by removing 70 to 90% of the particles from the output of thenebulizer prior to delivery results in a significant reduction inrain-out at the cannula while delivering sufficient amounts of the drugto the patient for the required treatment.

It is therefore advantageous to remove excess medicament from the outputof the nebulizer before the nebulized particles reach the nasal cannula.In one option, excess rain-out can be removed from the flow of breathinggas at the patient proximate end of the delivery tube just beforeconnection to the nasal cannula. However this requires a reservoir orrain-out trap near the patient to collect the liquid medicament, whichmay be uncomfortable and cumbersome for the patient. The rain-out trapmust also be held at a particular angle to avoid a bolus of drug beingdelivered to the patient, which can be challenging when the patientmoves during treatment. In another option, excess rain-out can beremoved at the machine proximate end of the delivery tube. However inHFT systems the high velocity flow is very likely to causere-entrainment of the removed excess rain-out back into the flow ofbreathing gas. The removed excess rain-out would also need to be trappedand disposed of Considering that 70 to 90% of the nebulized drug isremoved to reduce the rain-out in the system as mentioned above,disposal of such a large proportion of the nebulized drug would meanthat more of the drug would be necessary to maintain the efficacy of thetreatment. This could incur significant cost if the drug is expensive.

SUMMARY

Disclosed herein are approaches for addressing various of the problemsand shortcomings of the state of the art, as identified above. Moreparticularly, disclosed herein are systems and methods for providingrespiratory therapy to a patient. According to a first embodiment of thepresent disclosure, there is provided a system comprising a nebulizeroperable to aerosolize a medicament where the medicament is transformedfrom a liquid into an aerosol of medicament particles. The system alsocomprises a cylindrical mixing chamber having an inner surface, an inletport, an outlet port, an aerosol port in fluid communication with thenebulizer, and a drainage port. The inlet port is configured to receivea flow of breathing gas from a source of breathing gas. The outlet porthas a first end and a second end, the second end external to the mixingchamber and configured to interfit with a delivery tube for delivery ofthe flow of breathing gas to the patient. The mixing chamber isconfigured to receive a flow of aerosol from the nebulizer via theaerosol port, entrain aerosol into the flow of breathing gas, anddeliver the breathing gas entrained with aerosol to the outlet port. Thesystem further comprises an impacting cap in fluid communication withthe mixing chamber, the impacting cap having a sloped inner surface andforming a settling volume (or settling space) with the mixing chamber.The settling volume may have a diameter that is larger a diameter of theinlet port and a diameter of the aerosol port. The mixing chamber may beconfigured to receive the aerosol in the settling volume and cause aportion of the aerosol to coalesce into droplets in or on any of thesettling volume, the inner wall of the mixing chamber, and the slopedinner surface of the impacting cap. The inner wall of the mixing chamberand the sloped inner surface of the impacting cap may be configured todirect rain-out (also referred to as liquid or condensate in the presentdisclosure) resulting from the droplets to the drainage port. The systemincludes a recirculation tube adapted to return the rain-out to thenebulizer.

The system causes a portion of the nebulized medicament particles tocoalesce on the inner walls of the mixing chamber and the inner walls ofthe impacting cap. These droplets result in rain-out which collects atthe drainage port of the mixing chamber. The nebulized medicamentremaining in the mixing chamber is entrained into the flow of breathinggas and delivered to the patient. The system therefore encouragesrain-out to occur before entrainment of the remaining nebulizedparticles into the flow of breathing gas. In this manner, the breathinggas entrained with the remaining nebulized medicament is less likely torain-out in the delivery tube when it is transported to the patient.This increases the efficacy of the treatment as the remaining nebulizedparticles that are entrained in the flow of breathing gas are lesslikely to rain-out. This a significantly higher proportion of thenebulized particles are inhaled by the patient. Rain-out is less likelyin the delivery tube after the breathing gas entrained with theremaining nebulized medicament leaves the mixing chamber. Thus no bolusof liquid medicament builds up in the delivery tube or nasal cannula,thereby reducing patient discomfort during treatment. The recirculationtube delivers the rain-out to the nebulizer to be reused. This minimizeswastage of the therapy drug and reduces the cost of such therapyespecially when expensive drugs are used.

According to a second embodiment of the present disclosure, there isprovided a nebulizer adaptor for providing continuous aerosol therapy toa patient. The adaptor comprises a cylindrical mixing chamber having aninlet port, an outlet port, an aerosol port in fluid communication withthe nebulizer, and a drainage port. The inlet port is configured toreceive a flow of breathing gas from a source of breathing gas. Theoutlet port has a first end and a second end, the second end external tothe mixing chamber and configured to interfit with a delivery tube fordelivery of the flow of breathing gas to the patient. The mixing chamberis configured to receive a flow of aerosolized medicament from avibrating mesh nebulizer via the aerosol port, entrain aerosol into theflow of breathing gas, and deliver the breathing gas entrained withaerosol to the outlet port. The adaptor also comprises an impacting capin fluid communication with the mixing chamber, the impacting cap havinga sloped inner surface and forming a settling volume with the mixingchamber. The mixing chamber has a diameter that is larger than adiameter of the inlet port and a diameter of the aerosol port, and isconfigured to receive the aerosol in the settling volume and cause afirst portion of the aerosol to coalesce into droplets in or on any ofthe settling volume, the inner wall of the mixing chamber, and thesloped inner surface of the impacting cap. Further, the inner wall ofthe mixing chamber and the sloped inner surface of the impacting capbeing configured to direct rain-out resulting from the droplets towardthe drainage port.

In some implementations, the impacting cap may be located above theinlet port, outlet port, aerosol port and drainage port. The drainageport may be located below the inlet port, outlet port, aerosol port andimpacting cap. This ensures that the rain-out is directed towards thedrainage port and is distanced from the outlet port so that the rain-outdoes not get re-entrained into the flow of breathing gas. In certainimplementations, the first end of the outlet port may be orthogonallyoriented to the inlet port. The first end of the outlet port may bevertically spaced from the inlet port of the mixing chamber. The firstend of the outlet port may extend into the mixing chamber. Suchconfigurations encourage the nebulized particles and breathing gas tomove up the mixing chamber, inducing rain-out along the way.

In certain implementations, the inlet port and the outlet port may be influid communication such that the breathing gas entrained with aerosolmay be provided to the delivery tube via the second end of the outletport. The outlet port may be arranged orthogonally to the inlet port.

In some implementations, the impacting cap may be cone shaped. The wallsof the impacting cap may be symmetrical about the outlet port. Theimpacting cap may also be contiguous with the mixing chamber. Thisencourages the rain-out to slide down the inner walls of the impactingcap towards the drainage port. This reduces the risk of the rain-outfrom becoming re-entrained into the flow of breathing gas at the outletport. This also minimizes the possibility of the rain-out flowingdirectly into the outlet port.

In some implementations, the nebulizer may comprise a reservoircontaining the medicament. The rain-out from the recirculation tube maybe dumped and stored in the nebulizer reservoir. Further, the nebulizermay comprise an aerosol chamber. This allows the stream of nebulizedparticles leaving the nebulizer outlet to reach an equilibrium velocitybefore being introduced into the mixing chamber. The aerosol chamber maycomprise a baffle, that may be adjustable, to control the stream ofnebulized particles (and hence drug delivery rate) into the mixingchamber.

In certain implementations, the recirculation tube may comprise anauxiliary port for the introduction of additional or differentmedicament to the nebulizer. This additional or different medicamentgets dumped into the nebulizer, which subsequently becomes nebulized anddelivered to the patient. In some embodiments, the mixing chamber maycomprise a collection compartment adjacent to the drainage port toenable the rain-out to collect prior to being drained by the drainageport. A stopcock may also be coupled to the drainage port or therecirculation tube to enable the rain-out to be stored in the collectioncompartment prior to being recycled to the nebulizer. This may bebeneficial when introducing different medicament into the nebulizer viathe auxiliary port.

In further implementations, the drainage port may be connected to areceptacle via a siphon to drain excess rain-out away from thenebulizer. This allows a swap out of medicament as the patient's therapyrequirements change. The siphon may have a valve for ease of control.The drainage port may be coupled to a flow restrictor to control a flowrate of the recirculated rain-out.

In some implementations, the mesh is configured to vibrate in order toaerosolize the medicament. In certain implementations, a second portionof the aerosol coalesces into droplets on a surface of the mesh duringvibration. In other implementations, a conduit fluidically connects theinlet port and the aerosol port, the conduit in fluid communication withthe mixing chamber for the delivery of breathing gas from the inlet portto the mixing chamber. In further implementations, the conduit isaligned along a direction that is normal to the surface of the mesh asthe conduit fluidically connects the inlet port to the aerosol port. Insome implementations, the conduit directs the breathing gas received bythe inlet port to impinge upon the surface of the mesh as it flows alongthe conduit to the mixing chamber. In certain implementations, thebreathing gas removes the droplets from the surface of the mesh uponimpingement.

In other implementations, the nebulizer is removable from the aerosolport of the mixing chamber. In some implementations, a removable cap isconfigured to seal the aerosol port after removal of the nebulizer. Incertain implementations, the conduit directs the flow of breathing gasto the mixing chamber and output port for delivery to the patient afterthe aerosol port is sealed.

In some implementations, the medicament may comprise at least one of:bronchodilators, surfactants and antibiotics. The medicament maycomprise at least one of: Albuterol (Ventolin), Salbutamol (Proventil),Levosalbutamol/Levalbuterol (Xopenex), Curosurf (ChiesiPharmaceuticals), Alveofact (Boehringer Ingelheim), Survanta (AbbottLaboratories), Exosurf (Glaxo Wellcome), Surfaxin (DiscoveryLaboratories), macrolides, erythromycin, clarithromycin, azithromycin,glycopeptides, vancomycin, teicoplanin, oxazoldinone,quinupristin/dalfopristen, aminoglycosides, gentamicin, tobramycin,amikacin, streptomycin, netilmicin, quinolones, ciprofloxacin,ofloxacin, levofloxacin, tetracyclines, oxytetracycline, doxycycline,minocycline, cotrimoxazole, colistin, imepinim, and meripenim.

According to a third embodiment of the present disclosure, there isprovided a method for providing respiratory therapy to a patient. Themethod comprises providing a flow of breathing gas to a settling volumedefined by a mixing chamber and an impacting cap in fluid communicationwith the mixing chamber, generating an aerosol from a nebulizercontaining a medicament, and providing the aerosol to the settlingvolume. The method also comprises coalescing a first portion of theaerosol into droplets in or on any of the settling volume, an inner wallof the mixing chamber and a sloped inner surface of the impacting cap,and recirculating rain-out resulting from the droplets to the nebulizer.Further, the method comprises entraining a remaining portion of theaerosol into the flow of breathing gas within the settling volume, anddelivering the breathing gas entrained with aerosol from the settlingvolume to the patient. In this manner, the breathing gas entrained withthe remaining nebulized medicament is less likely to rain-out in adelivery tube when it is transported to the patient. This increases theefficacy of the treatment as the remaining nebulized particles that areentrained in the flow of breathing gas are less likely to rain-out. Thisa significantly higher proportion of the nebulized particles are inhaledby the patient. Rain-out is less likely in the delivery tube after thebreathing gas entrained with the remaining nebulized medicament leavesthe mixing chamber. Thus no bolus of liquid medicament builds up in thedelivery tube or nasal cannula, thereby reducing patient discomfortduring treatment. A recirculation tube delivers the rain-out to thenebulizer to be reused. This minimizes wastage of the therapy drug andreduces the cost of such therapy especially when expensive drugs areused.

In some implementations, the method may further comprise reducing a flowvelocity of the breathing gas and the aerosol upon entry to the mixingchamber. The enables the aerosol particles to coalesce into dropletswithin the settling volume. This also allows the aerosol particles tocoalesce on the inner wall of the mixing chamber and/or the sloped innersurface of the impacting cap. In some implementations, the method mayfurther comprise storing the rain-out in a reservoir contained withinthe nebulizer. In this manner, the rain-out from the recirculation tubemay be dumped and stored in the nebulizer reservoir for furthertreatment/use. In certain implementations, the method may comprisestoring the aerosol in an aerosol chamber prior to providing the aerosolto the mixing chamber. This allows the stream of nebulized particlesleaving the nebulizer outlet to reach an equilibrium velocity beforebeing introduced into the mixing chamber. In further implementations,the method may comprise adjusting the amount of aerosol delivered to themixing chamber with a baffle. This allows for control of the stream ofnebulized particles (and hence drug delivery rate) into the mixingchamber.

In some implementations, the method may comprise providing additionaldrug to the nebulizer using an auxiliary port connected to therecirculation tube. This additional or different medicament gets dumpedinto the nebulizer, which subsequently becomes nebulized and deliveredto the patient. In certain implementations, the method may additionalcomprise controlling the flow rate of the recirculating rain-out with aflow restrictor coupled to the drainage port. In furtherimplementations, the method comprises removing excess rain-out from therecirculation tube via a siphon connected to a drug receptacle. Thisallows for excess rain-out to be drained away from the nebulizer,thereby allowing for a swap out of medicament as the patient's therapyrequirements change. In other implementations, the method comprisesstoring the rain-out in a collection compartment of the mixing chamberprior to recirculating the rain-out to the nebulizer.

In further implementations, the method comprises providing the flow ofbreathing gas to the settling volume via a conduit that directs thebreathing gas to impinge upon a surface of the mesh along a directionthat is normal to the surface of the mesh. In other implementations, themethod comprises flowing the breathing gas at a higher rate than thatused for delivery to the patient, and removing aerosol that hascoalesced into droplets on the surface of the mesh by the impingement ofthe breathing gas on the surface of the mesh. In certainimplementations, the method comprises removing the nebulizer from theaerosol port, sealing the aerosol port, and directing the flow ofbreathing gas to the settling volume for delivery to the patient.

In some implementations, the medicament may comprise at least one of:bronchodilators, surfactants and antibiotics. The medicament maycomprise at least one of: Albuterol (Ventolin), Salbutamol (Proventil),Levosalbutamol/Levalbuterol (Xopenex), Curosurf (ChiesiPharmaceuticals), Alveofact (Boehringer Ingelheim), Survanta (AbbottLaboratories), Exosurf (Glaxo Wellcome), Surfaxin (DiscoveryLaboratories), macrolides, erythromycin, clarithromycin, azithromycin,glycopeptides, vancomycin, teicoplanin, oxazoldinone,quinupristin/dalfopristen, aminoglycosides, gentamicin, tobramycin,amikacin, streptomycin, netilmicin, quinolones, ciprofloxacin,ofloxacin, levofloxacin, tetracyclines, oxytetracycline, doxycycline,minocycline, cotrimoxazole, colistin, imepinim, and meripenim.

Variations and modifications will occur to those of skill in the artafter reviewing this disclosure. The disclosed features may beimplemented, in any combination and subcombination (including multipledependent combinations and subcombinations), with one or more otherfeatures described herein. The various features described or illustratedabove, including any components thereof, may be combined or integratedin other systems. Moreover, certain features may be omitted or notimplemented.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other objects and advantages will be apparent uponconsideration of the following detailed description, taken inconjunction with the accompanying drawings, in which like referencecharacters refer to like parts throughout, and in which:

FIG. 1 shows an illustrative machine proximate nebulizer according to anembodiment of the present disclosure;

FIG. 2 shows an illustrative cross sectional view of the machineproximate nebulizer of FIG. 1 ; and

FIGS. 3A-3E show illustrative perspective views of an embodiment of amachine proximate nebulizer adaptor according to an embodiment of thepresent disclosure;

FIG. 4 shows a flowchart of an illustrative method of providing machineproximate nebulization therapy to a patient;

FIG. 5 shows a flowchart of an illustrative method of cleaning thevibrating mesh of a nebulizer attached to the machine proximatenebulizer adaptor of FIGS. 3A-3E; and

FIG. 6 shows a flowchart of an illustrative method of providingcontinuous respiratory therapy to a patient using the machine proximatenebulizer adaptor of FIGS. 3A-3E.

DETAILED DESCRIPTION

To provide an overall understanding of the systems and methods describedherein, certain illustrative implementations will be described. Althoughthe implementations and features described herein are specificallydescribed for use in connection with a high flow therapy system, it willbe understood that all the components and other features outlined belowmay be combined with one another in any suitable manner and may beadapted and applied to other types of respiratory therapy andrespiratory therapy devices, including low flow oxygen therapy,continuous positive airway pressure therapy (CPAP), mechanicalventilation, oxygen masks, Venturi masks, and Tracheostomy masks.Furthermore, it should be noted that while certain implementations arediscussed herein with regards to systems and methods for respiratorytherapy, these various implementations may be used in variouscombinations to increase both the efficacy of treatment and thepatient's overall level of comfort during the treatment.

Disclosed herein are systems and methods that provide respiratorytherapy to a patient using a mixing chamber in fluid communication withan impacting cap, the mixing chamber and impacting cap creating asettling volume, the mixing chamber being attached to a source ofbreathing gas. The mixing chamber is also coupled to a nebulizer and isprovided with a stream of nebulized medicament therefrom. The mixingchamber and impacting cap is described below and mixes a flow ofbreathing gas and the stream of nebulized medicament so as to cause aportion of the nebulized medicament particles to impact on the innerwalls of the mixing chamber and impacting cap. The aerosol particlescoalesce in or on any of the settling volume, the inner wall of themixing chamber, and the sloped inner surface of the impacting cap, andform rain-out, which collects at a drainage port of the mixing chamber.A recirculation tube is attached to the drainage port and is adapted todeliver the rain-out to the nebulizer to be reused. This increases theefficiency of the system as wastage of the therapy drug is kept to aminimum. This may have an impact on the cost of such therapy forexpensive drugs.

The nebulized medicament remaining in the mixing chamber is entrainedinto the flow of breathing gas and delivered to the patient. In thesystem of the present disclosure, the mixing chamber and impacting capencourages rain-out to occur before entrainment of the remainingnebulized particles into the flow of breathing gas. The flow velocity ofthe aerosol particles is reduced upon entry to the settling volume. Theflow of breathing gas into the mixing chamber causes the aerosolparticles to me moved upwards in the settling volume, thereby affordingthe a portion of the aerosol particles to impact the inner wall of themixing chamber and the sloped inner surface of the impacting cap. Inthis manner, the breathing gas entrained with the nebulized medicamentis made up of remaining aerosol particles and is less likely to rain-outin the delivery tube when it is transported to the patient. This means asignificantly higher proportion of the nebulized particles that reachthe patient connector (e.g. nasal cannula) are inhaled by the patient.Rain-out is less likely in the delivery tube after the breathing gasentrained with the remaining nebulized medicament leaves the mixingchamber and so a rain-out trap is not required at the end of thedelivery tube.

The impacting cap may be located above the inlet port, outlet port,aerosol port and drainage port. The drainage port may be located belowthe inlet port, outlet port, aerosol port and impacting cap. Thisensures that the rain-out is directed towards the drainage port and isdistanced from the outlet port so that the rain-out does not getre-entrained into the flow of breathing gas. The first end of the outletport may be orthogonally oriented to the inlet port. The first end ofthe outlet port may be vertically spaced from the inlet port of themixing chamber. The first end of the outlet port may extend into themixing chamber. Such configurations encourage the nebulized particlesand breathing gas to move up the mixing chamber, inducing rain-out alongthe way.

The impacting cap may be cone shaped. The inner walls of the impactingcap may be symmetrical about the outlet port. The impacting cap may alsobe contiguous with the mixing chamber. This encourages the rain-out toslide down the inner walls of the impacting cap towards the drainageport. This reduces the risk of the rain-out from becoming re-entrainedinto the flow of breathing gas at the outlet port. This also minimizesthe possibility of the rain-out flowing directly into the outlet port.

The nebulizer may comprise an aerosol chamber. This allows the stream ofnebulized particles leaving the nebulizer outlet to reach an equilibriumvelocity before being introduced into the mixing chamber. The aerosolchamber may comprise a baffle, that may be adjustable, to control thestream of nebulized particles (and hence drug delivery rate) into themixing chamber.

The recirculation tube may comprise an auxiliary port for theintroduction of additional or different medicament to the nebulizer.This additional or different medicament gets dumped into the nebulizer,which subsequently becomes nebulized and delivered to the patient. Themixing chamber may comprise a collection compartment adjacent to thedrainage port to enable the rain-out to collect prior to being drainedby the drainage port. A stopcock may also be coupled to the drainageport or the recirculation tube to enable the condensate to be stored inthe collection compartment prior to being recycled to the nebulizer.This may be beneficial when introducing different medicament into thenebulizer via the auxiliary port. The drainage port may be connected toa receptacle via a siphon to drain excess condensate away from thenebulizer. This allows a swap out of medicament as the patient's therapyrequirements change. The siphon may have a valve for ease of control.

FIG. 1 shows an illustrative system for providing respiratory therapy toa patient. The system comprises a mixing chamber 100 connected to animpacting cap 200 and a nebulizer 300. The mixing chamber 100 is influid communication with the impacting cap 200, and together form asettling volume. The nebulizer 300 is operable to provide a stream ofnebulized particles to the mixing chamber 100. A source of breathing gasis attached to the mixing chamber 100 so as to provide the mixingchamber 100 with a flow of breathing gas, as indicated by the arrow ‘A’in FIG. 1 . The breathing gas may be heated and humidified to reducepatient discomfort. The stream of nebulized particles generated by thenebulizer 300 is mixed with the flow of breathing gas in the mixingchamber 100. Here a portion of the nebulized particles collide with theinner walls of the impacting cap 200 and coalesce into droplets to formrain-out. The remaining nebulized particles are entrained in the flow ofbreathing gas and are fed into a delivery tube 400 connected to themixing chamber 100, as indicated by the arrow ‘B’ in FIG. 1 .

The delivery tube 400 is in fluid communication with a nasal cannulaattached the patient such that the remaining nebulized particlesentrained in the flow of breathing gas are provided to the patientthereby providing respiratory therapy to the patient. Exemplary nasalcannulas that can be used in conjunction with the present disclosure aredescribed in U.S. patent application Ser. Nos. 13/665,100, 15/199,158and 62/555,945, the contents of which are hereby incorporated byreference in their entirety. Alternatively, any nasal cannula can beused with the system and method of the present disclosure. The rain-outin the mixing chamber 100 is returned to the nebulizer 300 via arecirculating tube 500 to be re-used as necessary. In certainembodiments, the mixing chamber 100 is located at the machine end of thedelivery tube 400, away from the patient and proximate to the source ofbreathing gas.

FIG. 2 shows an illustrative detailed cross-section of the system inFIG. 1 . As can be seen from FIG. 2 , the mixing chamber 100 comprises abody section 110 having an opening 112 to which the impacting cap 200 isconnected. The mixing chamber 100 is in fluid communication with theimpacting cap 200, and together form a settling volume. The mixingchamber 100 also comprises an inlet port 120, an aerosol port 130, anoutlet port 140 and a drainage port 160. The mixing chamber 100 may alsocomprise a collection chamber 150 for collecting rain-out that developsin the mixing chamber 100. The inlet port 120 is connected to the sourceof breathing gas via a feed tube to provide the mixing chamber 100 withthe flow of breathing gas. In some embodiments the inlet port 120 may becylindrical. The inlet port 120 may have a diameter that is smaller thanthe diameter of the body section 110 of the mixing chamber 100. Thiscauses the flow velocity of breathing gas to be reduced upon enteringthe settling volume defined by the mixing chamber 100 and the impactingcap 200. In certain embodiments, the inlet port 120 may be arrangedabove the drainage port 160. While FIG. 2 illustrates the body section110 of the mixing chamber 100 as being cylindrical having an axis 114and a diameter, in some embodiments, the body section 110 can be of anyshape having substantially vertical walls without deviating from thescope of the present disclosure. In certain embodiments, the diameter ofthe mixing chamber 100 may be significantly larger than that of the feedtube through which the source of breathing gas is provided. In certainembodiments, the cross-section of the mixing chamber 100 may besignificantly larger than the cross-section of the inlet port 120 andthe aerosol port 130. This reduces the flow velocity of the breathinggas and the nebulized particles upon entry to the settling volumedefined by the mixing chamber 100 and the impacting cap 200.

The source of breathing gas may be configured to provide, for example,breathing gas at flow rates between 1 and 8 lpm for infants, between 5and 20 lpm for pediatric patients, or up to 40 lpm for adults. In someembodiments, the breathing gas is heated and humidified to increasepatient comfort. Suitable sources of heated and humidified gas will beknown to one of ordinary skill in the art. For example, the source maybe the Vapotherm Flowrest System, Vapotherm Careflow System, PrecisionFlow unit, or the Vapotherm 2000i, all of which are provided byVapotherm, Inc. of Exeter, N.H., USA. Other suitable sources ofbreathing gas will be known to one of ordinary skill in the art from thedescription herein.

The impacting cap 200 comprises sloped portions 210, 220 and a couplingportion 240. The sloped portions 210, 220 form a surface on which thenebulized particles from nebulizer 300 collide when in the settlingvolume. In some embodiments, the sloped portions 210, 220 may besymmetrical about the axis 114 of the mixing chamber 100. In certainembodiments in which the body section 110 of the mixing chamber 100 is acylinder, the sloped portions 210, 220 form a cone with an apex 230. Thecone is symmetrical about the axis 114 of the mixing chamber 100 andtherefore aligns the apex 230 with the axis 114. In some embodiments thebody section 110 may be of any suitable shape that is symmetrical aboutthe axis 114 and provides at least one surface for the nebulizerparticles to collide with. Coupling portion 240 may be a cylinder withan axis that aligns with axis 114, as shown in FIG. 2 . Coupling portion240 may have a diameter that is marginally smaller than the diameter ofthe body section 110 thereby facilitating an interference fit betweenthe impacting cap 200 and the mixing chamber 100. In other embodiments,the body section 110 of the mixing chamber 100 may have an internalthread that mates with an exterior thread formed on the coupling portion240 of the impacting cap 200. The edge 212 of the coupling portion 240may be beveled so as to provide a smooth transition for droplets thatcoalesce on the inner walls of the impacting cap 200 to slide down theinner wall of the mixing chamber 100. In some embodiments, the mixingchamber 100 and the impacting cap 200 may be contiguous. In certainembodiments, the mixing chamber 100 and the impacting cap 200 may beintegrally formed. In some embodiments, the impacting cap 200 is locatedabove the inlet port 120, the outlet port 140, the aerosol port 130 andthe drainage port 160.

The outlet port 140 comprises a first end 142 and a second end 144, andis arranged such that the first end 142 extends into the body section110 of the mixing chamber 100, and the second end 144 of the outlet port140 is located external to the mixing chamber 100. The second end 144 ofthe outlet port 140 is adapted to interfit with a first end of thedelivery tube 400 so as to transport the nebulized particles entrainedinto the flow of breathing gas from the mixing chamber 100 to thepatient. A second end of the delivery tube 400 is attached to a nasalcannula attached to the patient such that the nebulized particles can beinhaled by the patient. In certain embodiments, the outlet port 140 iscylindrically shaped with an axis that aligns with axis 114 of themixing chamber. In this arrangement, the outlet port 140 is orthogonallyoriented to the inlet port 120 of the mixing chamber 100. In certainembodiments, the first end 142 of the outlet port 140 is arranged suchthat it is located above the inlet port 120, the aerosol port 130, thecollection chamber 150 and the drainage port 160. In certainembodiments, the outlet port 142 may be vertically spaced from the inletport 120 of the mixing chamber 100. In some embodiments, the outlet port140 extends into the settling volume defined by the mixing chamber 100and the impacting cap 200.

Nebulizer 300 comprises an input port 310 that provides liquidmedicament to a reservoir 320 for storage prior to being nebulized.Nebulizer 300 further comprise an aerosol generating mechanism 330 thatis in fluid contact with the liquid medicament in reservoir 320. Theaerosol generating mechanism 330 is in fluid communication with anoutlet port 340. In certain embodiments, the aerosol generatingmechanism 300 may comprise a vibrating mesh that aerosolizes the liquidmedicament in the reservoir 320 into nebulized particles upon input ofan alternating voltage, for example. The nebulizer 300 is connected tothe mixing chamber 100 via the aerosol port 130, and is operable toprovide the mixing chamber 100 with a stream of nebulized particles 135from the nebulizer output port 340. The aerosol port 130 is of adiameter that is smaller than that of the body section 110 of the mixingchamber 100. This causes the flow velocity of nebulized particles 135 tobe reduced upon entering the settling volume.

In some embodiments, the nebulized particles 135 are fed into an aerosolchamber 350 prior to being introduced into the mixing chamber 100. Insome embodiments, the aerosol chamber 350 is cylindrical and has alarger diameter than the diameter of the nebulizer outlet port 340. Thisresults in a reduction in flow velocity of the particles 135 as theyenter the aerosol chamber 350. The aerosol chamber 350 thereforedisperses the particles 135 into the mixing chamber 110 at a lowerspeed. The aerosol chamber 350 may be attached to the nebulizer outletport 340. In certain embodiments, the aerosol chamber 350 may becontiguous with the nebulizer 300. The diameter of the aerosol chamber350 may be marginally smaller than the diameter of the aerosol port 130of the mixing chamber 100 thereby facilitating an interference fitbetween the aerosol port 130 and the aerosol chamber 350. In otherembodiments, the aerosol port 130 of the mixing chamber 100 may have aninternal thread that mates with an exterior thread formed on the aerosolchamber 350. In some embodiments, the aerosol chamber 350 may beprovided with a baffle that is positioned within the aerosol chamber 350between the nebulizer output port 340 and the point at which the aerosolport 130 adjoins the mixing chamber 100. The baffle enables the user tocontrol the proportion of nebulized particles 135 that is introducedinto the mixing chamber 100. In certain embodiments, the baffle may beadjustable to allow the user to adjust the rate at which the nebulizedparticles are introduced into the mixing chamber 100.

The stream of nebulized particles 135 enters the mixing chamber 100 viathe aerosol port 130 and is mixed with the flow of breathing gas in thesettling volume defined by the mixing chamber 100 and the impacting cap200. Due to the aforementioned diameter of the body section 110 of themixing chamber 100 in comparison with the diameter of the inlet port 120and the diameter of the aerosol port 130, the flow velocity of thebreathing gas and the flow velocity of the nebulized particles isreduced upon entry to the settling volume. Additionally, the flow ofbreathing gas supplied to the mixing chamber 100 effectively ‘pushes’the stream of nebulized particles 135 upwards within the settlingvolume. This results in the nebulized particles having an upwardvelocity in the settling volume. As a result the nebulized particles 135move upwards at a reduced speed and impinge both the inner walls of thebody section 110 of the mixing chamber 100 and the inner walls of theimpacting cap 200. This causes a portion of the nebulized particles tocoalesce on the inner walls of the body section 110 of the mixingchamber 100 and the inner walls of the impacting cap 200, thus resultingin rain-out. In some embodiments, due to the symmetrical configurationof sloped surfaces 210, 220 of the impacting cap 200 about the verticalaxis 114 of the mixing chamber 100, when the breathing gas impinges theimpacting cap 200, the breathing gas is directed downwards to the firstopening 142 of the outlet port 140.

Due to gravity, the rain-out moves downwards along the inner walls ofthe impacting cap 200 (as shown by arrow 214 in FIG. 2 ) and along theinner walls of the body section 110 of the mixing chamber 100 (as shownby arrow 114 in FIG. 1 ). The remaining nebulized particles areentrained with the breathing gas in the body section 110 of the mixingchamber 100 as they flow into the outlet port 140 via the first end 142for delivery to the patient. In this manner, a portion of the nebulizedparticles is forced to coalesce and rain-out on the inner walls of boththe body section 110 of the mixing chamber 100 and the sloped surfaces210, 220 of the impacting cap 200. This lowers the amount of nebulizedmedicament available in the mixing chamber 100 for entrainment into thebreathing gas at the first end 142 of the outlet port 140. In turn, thislowers the proportion of nebulized particles flowing through thedelivery tube 400 and thus reduces the possibility of further rain-outfrom occurring when the breathing gas, entrained with nebulizedparticles, is transported to the patient.

Mixing chamber 100 may also comprise a collection chamber 150 to collectany rain-out 152 that forms in the settling volume. Collection chamber150 may be vertically oriented with respect to the mixing chamber 100such that it is positioned at the very bottom of the mixing chamber 100.Collection chamber 150 may also be located away from the first end 142of the outlet port 140 to prevent re-entrainment of the rain-out backinto the flow of heated and humidified gas flowing into the firstopening 142 of the outlet port 140. The bottom of the collection chamber150 may additionally be fitted with a drainage port 160 to facilitateremoval of the rain-out from the mixing chamber 100. Collection chamber150 may include a base that is angled or sloped so as to direct therain-out towards the drainage port 160. In certain embodiments, thecollection chamber 150 and the drainage port 160 may be arranged suchthat they are positioned below the inlet port 120, the first end 142 ofthe outlet port 140, and the aerosol port 130. It will be understoodthat in order to prevent rain-out from entering the outlet port 140, andto assist in the collection of rain-out in the collection chamber 150,there are no horizontal surfaces or stepped edges near the first end 142of the outlet port 140.

Drainage port 160 may be fitted with a recirculation tube 500 such thatthe rain-out 152 is drained from the collection chamber 150. A first end510 of the recirculation tube 500 is attached to the drainage port 160and a second end 520 of the recirculation tube 500 is attached to theinlet 310 of the nebulizer 300. In this configuration, the rain-out 152that is drained from the collection chamber 150 is dumped into thereservoir 320 of the nebulizer 300 via the inlet 310. In this manner,the excess medicament that rains-out in the settling volume is recycledback to the reservoir 320 of the nebulizer 300. The rain-out isreintroduced into the reservoir 320 to be nebulized as a stream ofnebulized particles 135 again. This prevents any wastage of medicament,and is particularly important for treatments involving expensive drugs.

The back pressure from the delivery tube 400 and the nasal cannulaassists with the recycling of the rained-out medicament. Here the backpressure acts on the rain-out 152 in the collection chamber 150 and issufficient to push the rain-out 152 through the drainage port 160, alongthe length of the recirculation tube 500 in the direction indicated byarrow 530, and into the nebulizer reservoir 320. In some embodiments,the recirculation tube 500 may be dimensioned to have a diametersuitable to allow adequate flow of rain-out from the drainage port 160to the nebulizer 300 while allowing only a small fraction of thebreathing gas to enter into the recirculation tube 500.

In certain embodiments, a flow restrictor may be attached to thedrainage port 160 to control the flowrate of the rain-out as it flowsthrough the recirculation tube 500 to the nebulizer 300. Additionally,in further embodiments, the drainage port 160 may be adapted with asiphon to drain some of the rain-out away from the recirculation tube500 and into an excess drug tank (not shown) for disposal. This wouldenable a user to drain any excess medicament from the system withouthaving to disconnect the recirculation tube 500. In some embodiments,the drainage port 160 or the recirculation tube 500 may be adapted witha stopcock to allow a user to stop the flow of the rain-out therethroughso as to allow the rain-out to be stored in the collection compartment150 of the mixing chamber 100. Additionally, the recirculation tube 500may be provided with an auxiliary port (not shown) that is in fluidcommunication with the recirculating tube. The auxiliary port enables auser to inject additional or different medicament into the recirculationtube 500 that may be needed during the course of respiratory therapy.This additional or different medicament gets dumped into the reservoir320 of the nebulizer 300, which will subsequently become nebulized anddelivered to the patient.

Vibrating mesh nebulizers, such as nebulizer 300, also generatecondensation (water droplets or droplets of medicament that has not beenaerosolized) on the surface and/or at the edge of the vibrating meshduring operation. These droplets can slow or completely stop the aerosolproduction until the droplets fall off the surface of the mesh, or areshaken free. FIGS. 3A-3E illustrate several perspective views 601-605 ofan exemplary embodiment of a nebulizer adaptor 600 suitable forreceiving a nebulizer, such as the vibrating mesh nebulizer 300 asdescribed in relation to FIGS. 1-2 , for the provision of continuousaerosol therapy to a patient. The embodiments in FIGS. 3A-3E address thecondensation issue associated with vibrating mesh nebulizers, while alsoproviding continuous aerosol therapy to the patient.

FIGS. 3A-3E retains the features from the embodiments described inrelation to FIGS. 1-2 , as indicated by reference numbers in FIGS.3A-3E, and thus the description of these similar features are omittedfor brevity. Adaptor 600 is similar to the body section 110 of themixing chamber 100 as described in the foregoing, with the exceptionthat the aerosol port 130 is oriented such that its axis 606 issubstantially parallel to the axis 114 of the mixing chamber 100. Inadaptor 600, the inlet port 120 is arranged orthogonally with respect tothe axis 606 of the aerosol port 130. Adaptor 600 forms a conduit 620between the inlet port 120 and the aerosol port for the passage ofbreathing gas from a source of breathing gas (not shown). The passage ofbreathing gas is indicated by arrow C in FIG. 3D. The conduit 620 isaligned with the axis 606 of the aerosol port 130. In someimplementations, the breathing gas may be heated and humidified.

A vibrating mesh nebulizer is connected to the aerosol port 130 of theadaptor 600. The nebulizer is operable to provide a stream of nebulizedparticles to the adaptor 600 for entrainment into the flow of breathinggas for delivery to the patient. Here the nebulized particles from anebulizer connected to the aerosol port 130 are entrained into flow C ofbreathing gas in conduit 620, and the mixed stream is delivered to thesettling volume of the mixing chamber 100 for delivery to the patientvia the outlet port 140, in the manner as detailed with respect to FIGS.1-2 as described above.

While not depicted in FIGS. 3A-3E, when the nebulizer is connected tothe aerosol port 130, the mesh 330 of the nebulizer is positioned suchthat the axis 606 of the aerosol port 130 is normal to the surface ofthe mesh 330 (mesh 330 shown in FIG. 3D for reference). Due to theorientation of the conduit 620, when the breathing gas flows in theconduit 620 from inlet port 120, the flow of the breathing gas isdirected to impinge upon the surface of the mesh 330 in a direction thatis normal to the surface of the mesh 330, as shown in FIG. 3D. In effectthe direction of flow of breathing gas as it impinges the surface ofmesh 330 is aligned with the axis 606 of the aerosol port 130. Theorientation of the flow of breathing gas with respect to the mesh 330 ofa nebulizer connected to the aerosol port 130 enables the condensationthat builds up on the surface and edges of the mesh 330 to be removed.Such removal of condensate from the surface and edges of the mesh clearsthe mesh from any blockages, thereby improving the efficiency of themesh in generating aerosolized medicament for entrainment with breathinggas within the adaptor 600 for delivery to the patient. In certainimplementations, the flowrate of breathing gas from the inlet 120 isincreased above the flowrate used for treatment of the patient whencleaning of the mesh 330 is desired. The increased flowrate jetsbreathing gas at the nebulizer, at a direction normal to the surface ofthe mesh 330, causing any droplets that may have developed duringoperation to be shaken off.

Adaptor 600 also comprises attachment means, such as snap attachments630 on its outer surface, as shown in FIG. 3B. Such snap attachments 630enable the adaptor 600 to be attached to a capital unit, such as thePrecision Flow by Vapotherm, Inc. of Exeter, N.H. This enables theadaptor 600 to be compactly and rigidly attached to the body of suchcapital units and allows a supply of breathing gas to be fed into theinlet port 120. In the case of the Precision Flow, the breathing gas maybe heated and humidified prior to being fed into the inlet port 120.

In some implementations, nebulizer adaptor 600 may comprise a removablecap 640 that is attached to the outer surface of the aerosol port 130.When aerosol therapy for a patient has concluded, the mesh nebulizer isremoved from the aerosol port 130. In order to continue to providebreathing gas to the patient after aerosol therapy and withoutdisconnecting the adaptor 600, the cap 640 is inserted into the aerosolport 640. This seals the aerosol port 640. Breathing gas from the inletport 120 then flows along conduit 620 and into the settling volume ofthe mixing chamber 100 for delivery to the patient via the outlet 140.Thus the adaptor 600 enables the continuous supply of breathing gas tothe patient without interruption.

FIG. 4 shows a flowchart of an illustrative method 700 for providingrespiratory therapy to a patient. The method 700 begins at step 710where a source of breathing gas is attached to a mixing chamber. Themixing chamber may be cylindrical. The breathing gas may be heated andhumidified to reduce patient discomfort. The mixing chamber may have aninput port, an outlet port, an aerosol port and a drainage port, and thesource of breathing gas may be attached to the input port so as toprovide the mixing chamber with a flow of breathing gas. The input portand the aerosol port may have a smaller diameter than the diameter ofthe mixing chamber. The mixing chamber may also comprise a collectioncompartment for collecting any condensate or rain-out that develops inthe mixing chamber, the collection compartment being in fluidcommunication with the drainage port. Further, the mixing chamber mayalso have an impacting cap attached thereto, the impacting cap having atleast one sloped surface. The mixing chamber and the impacting captogether form a settling volume. The setting volume may have a diameterthat is larger than the diameter of the input port and the diameter ofthe aerosol port. Due to the geometry of the settling volume in relationto that of the input port, the velocity of the breathing gas may bereduced upon entry to the settling volume. Exemplary configurations ofthe mixing chamber have been described in relation to FIGS. 1, 2 and3A-3E in the foregoing.

At step 720, a stream of nebulized particles is generated by anebulizer. The nebulizer may comprise a mesh having holes such that whenthe mesh is in a first state, liquid medicament stored in a reservoir isnot permitted through the holes in the mesh, and when the mesh is in asecond state, the liquid medicament is permitted to pass though theholes in the mesh. The nebulizer may comprise a piezoelectric ring thatsurrounds the mesh. The piezoelectric ring may be reactive to an inputelectric signal so as to cause a change of state of the mesh from thefirst state to the second state (or vice versa). When the electricsignal is alternating in nature, such as an alternating voltage signal,for example, the mesh vibrates thereby generating a stream ofaerosolized medicament.

At step 730, the stream of nebulized particles is provided to theaerosol port of the mixing chamber. Due to the geometry of the settlingvolume in relation to that of the aerosol port, the velocity of thestream of nebulized particles may be reduced upon entry to the settlingvolume defined by the mixing chamber and the impacting cap. The streamof nebulized particles is mixed with the flow of breathing gas in thesettling volume. The nebulized particles are ‘pushed’ upwards by theflow of breathing gas from the input port, imparting an upward velocityto the nebulized particles.

As a result, at step 740, the nebulized particles move upwards withinthe mixing chamber and impinge the inner walls of the mixing chamber andthe inner walls of the sloped surface of the impacting cap. This causesa portion of the nebulized particles to coalesce on the inner walls ofthe mixing chamber and the sloped surface of the impacting cap,resulting in rain-out in the mixing chamber. The rain-out movesdownwards along the inner walls of the mixing chamber due to gravity andcollects in the collection compartment. A recirculating tube is attachedto the drainage port of the mixing chamber and connects the collectioncompartment to the reservoir in the nebulizer. The rain-out in thecollection compartment may therefore be drained and recycled back intothe reservoir to be reused.

At step 750, the nebulized particles remaining in the mixing chamber areentrained with the breathing gas in the mixing chamber and flow into theoutlet port. At step 760, the breathing gas entrained with the remainingnebulized particles is delivered to the patient via a delivery tubeconnected to the outlet port of the mixing chamber.

FIG. 5 shows a flowchart of an illustrative method 800 for cleaning thevibrating mesh of a nebulizer attached to the aerosol port of anebulizer adaptor, such as adaptor 600 in FIGS. 3A-3E. The method 800begins at step 810 where a flow of breathing gas is provided to theconduit 620 from inlet port 120. Here due to the orientation of theconduit 620 with respect to the aerosol port 130 m the flow of thebreathing gas is directed to impinge upon the surface of the mesh 330 ina direction that is normal to the surface of the mesh 330. In step 820,the flowrate of the breathing gas provided to the inlet port 120 isincreased above the flowrate used for delivery to the patient. Theincreased flowrate jets breathing gas at the nebulizer, at a directionnormal to the surface of the mesh 330, causing any condensation dropletsthat may have developed during operation of the vibrating mesh to beshaken off. This removes the condensation from the mesh (step 830)thereby improving the efficiency of the mesh in generating aerosolizedparticles from a liquid medicament.

FIG. 6 shows a flowchart of an illustrative method 900 for providingcontinuous respiratory therapy to a patient using a nebulizer adaptor,such as adaptor 600 in FIGS. 3A-3E. The method 900 begins at step 910where a nebulizer is removed from the aerosol port 130 of the adaptor600, for example when aerosol therapy for a patient has concluded. Aremovable cap 640 is then inserted into the aerosol port 640 to seal theaerosol port 640, as in step 920. Breathing gas from the inlet port 120is then provided to conduit 620 and directed into the settling volume ofthe mixing chamber 100 for delivery to the patient via the outlet 140,as in step 930. This provides breathing gas to the patient after aerosoltherapy and without having to disconnect the adaptor 600, therebyenabling the continuous supply of breathing gas to the patient withoutinterruption.

The foregoing is merely illustrative of the principles of thedisclosure, and the apparatuses can be practiced by other than thedescribed implementations, which are presented for purposes ofillustration and not of limitation. It is to be understood that theapparatuses disclosed herein, while shown for use in high flow therapysystems, may be applied to systems to be used in other ventilationcircuits.

Variations and modifications will occur to those of skill in the artafter reviewing this disclosure. For example, while the inlet port 120,the aerosol port 130 and the drainage port 160 are illustrated in FIGS.1 and 2 as being arranged orthogonally to the mixing chamber 100, itwill be understood that some or all of these ports may be arranged atany angle with respect to the mixing chamber 100 without deviating fromthe scope of the present disclosure. Further, while the nebulizer 300 isillustrated in FIGS. 1 and 2 as being fixed at an angle with respect tothe vertical axis 114 of the mixing chamber 100, the nebulizer 300 maybe oriented at any angle with respect to the axis 114 of the mixingchamber 100. Further, the nebulizer 300 may be rotationally oriented atany angle with respect to the axis 114 of the mixing chamber 100.

It will be understood that respiratory medications such asbronchodilators, surfactants or antibiotics, may be administered,independently or in combination with each other, through inhalationdirectly to the patient's lungs using any of the embodiments disclosedin the foregoing. Bronchodilators include, but are not limited to, anymedication for treating asthma or Chronic Obstructive Pulmonary Disease(“COPD”), such as Albuterol (Ventolin), Salbutamol (Proventil), andLevosalbutamol/Levalbuterol (Xopenex), for example. Surfactants include,but are not limited to, any medication effective for treating diseasesthat alter the surface active properties of the lung, such asrespiratory distress syndrome in premature infants (“iRDS”), acuterespiratory distress syndrome (ARDS), asthma, pneumonia, acute lunginjury (ALI), and meconium aspiration syndrome (MAS), for example.Surfactants for inhalation include, but are not limited to, Curosurf(Chiesi Pharmaceuticals), Alveofact (Boehringer Ingelheim), Survanta(Abbott Laboratories), Exosurf (Glaxo Wellcome), and Surfaxin (DiscoveryLaboratories), for example. Antibiotics include, but are not limited to,any antibiotics suitable for inhalation, such as macrolides (e.g.,erythromycin, clarithromycin, azithromycin), glycopeptides (e.g.vancomycin and teicoplanin), oxazoldinone, quinupristin/dalfopristen,aminoglycosides (e.g., gentamicin, tobramycin, amikacin, streptomycin,netilmicin), quinolones (e.g., ciprofloxacin, ofloxacin, levofloxacin),tetracyclines (e.g., oxytetracycline, doxycycline, minocycline),cotrimoxazole, colistin, imepinim, and meripenim, for example. In someembodiments, any medication may be administered through inhalationdirectly to the patient's lungs using any of the embodiments disclosedin the foregoing.

The disclosed features may be implemented, in any combination andsubcombination (including multiple dependent combinations andsubcombinations), with one or more other features described herein. Thevarious features described or illustrated above, including anycomponents thereof, may be combined or integrated in other systems.Moreover, certain features may be omitted or not implemented.

Examples of changes, substitutions, and alterations are ascertainable byone skilled in the art and could be made without departing from thescope of the information disclosed herein. All references cited hereinare incorporated by reference in their entirety and made part of thisapplication.

1. A system for providing respiratory therapy to a patient comprising: anebulizer comprising a mesh operable to aerosolize a medicament; and amixing chamber having an inlet port, an outlet port, an aerosol port influid communication with the nebulizer, and a drainage port, the inletport configured to receive a flow of breathing gas from a source ofbreathing gas, the outlet port having a first end and a second end, thesecond end external to the mixing chamber and configured to interfitwith a delivery tube for delivery of the flow of breathing gas to thepatient, the mixing chamber configured to receive a flow of aerosol fromthe nebulizer via the aerosol port, entrain aerosol into the flow ofbreathing gas, and deliver the breathing gas entrained with aerosol tothe outlet port, the mixing chamber configured to receive the aerosol inthe settling volume and cause a first portion of the aerosol to coalesceinto droplets in or on any of the settling volume, the inner wall of themixing chamber, and the sloped inner surface of the impacting cap, theinner wall of the mixing chamber being configured to direct rain-outresulting from the droplets toward the drainage port.
 2. The system ofclaim 1, wherein the impacting cap is located above the inlet port,outlet port, aerosol port and drainage port.
 3. The system of claim 1,wherein the drainage port is located below the inlet port, outlet port,aerosol port and impacting cap.
 4. The system of claim 1, wherein firstend of the outlet port is orthogonally oriented to the inlet port. 5.The system of claim 1, wherein the first end of the outlet port isvertically spaced from the inlet port of the mixing chamber.
 6. Thesystem of claim 1, wherein the first end of the outlet port extends intothe mixing chamber.
 7. The system of claim 1, wherein the inlet port andthe outlet port are in fluid communication such that the breathing gasentrained with aerosol is provided to the delivery tube via the secondend of the outlet port.
 8. The system of claim 1, wherein the outletport is arranged orthogonally to the inlet port.
 9. The system of claim1, wherein the inner surface of the impacting cap and the mixing chamberare contiguous.
 10. The system of claim 1, wherein the inner surface ofthe impacting cap is cone shaped.
 11. The system of claim 10, whereinthe impacting cap comprises walls that are symmetrical about the outletport.
 12. The system of claim 1, wherein the nebulizer comprises areservoir containing the medicament.
 13. The system of claim 1, whereinthe rain-out is stored in the nebulizer reservoir.
 14. The system ofclaim 1, wherein the nebulizer comprises an aerosol chamber into whichthe aerosol is generated.
 15. The system of claim 1, further comprisinga baffle positioned between the nebulizer and the mixing chamber. 16.The system of claim 15, wherein the baffle is adjustable to allowcontrol of a drug delivery rate to the patient.
 17. The system of claim82, wherein the recirculation tube comprises an auxiliary port for theintroduction of additional medicament to the nebulizer.
 18. The systemof claim 82, wherein the drainage port is coupled to a flow restrictorto control a flow rate of the recirculated rain-out.
 19. The system ofclaim 1, wherein the drainage port is connected to a receptacle viasiphon to drain excess rain-out away from the nebulizer.
 20. The systemof claim 19, wherein the siphon comprises a valve to control the amountof drained rain-out.
 21. The system of claim 1, wherein the mixingchamber comprises a collection compartment adjacent to the drainage portin which the rain-out collects prior to being drained by the drainageport.
 22. The system of claim 82, wherein a stopcock is coupled to thedrainage port or the recirculation tube to enable the rain-out to bestored in the collection compartment.
 23. The system of claim 1, whereinthe mesh is configured to vibrate in order to aerosolize the medicament.24. The system of claim 23, wherein a second portion of the aerosolcoalesces into droplets on a surface of the mesh during vibration. 25.The system of claim 24, further comprising a conduit fluidicallyconnecting the inlet port and the aerosol port, the conduit in fluidcommunication with the mixing chamber for the delivery of breathing gasfrom the inlet port to the mixing chamber.
 26. The system of claim 25,wherein the conduit is aligned along a direction that is normal to thesurface of the mesh as the conduit fluidically connects the inlet portto the aerosol port.
 27. The system of claim 26, wherein the conduitdirects the breathing gas received by the inlet port to impinge upon thesurface of the mesh as it flows along the conduit to the mixing chamber.28. The system of claim 27, wherein the breathing gas removes thedroplets from the surface of the mesh upon impingement.
 29. The systemof claim 1, wherein the nebulizer is removable from the aerosol port ofthe mixing chamber.
 30. The system of claim 29, further comprising aremovable cap configured to seal the aerosol port after removal of thenebulizer.
 31. The system of claim 30, wherein the conduit directs theflow of breathing gas to the mixing chamber and output port for deliveryto the patient after the aerosol port is sealed.
 32. The system of claim1, wherein the medicament comprises at least one of: bronchodilators,surfactants and antibiotics. 33-80. (canceled)
 81. The system of claim1, wherein the mixing chamber has a diameter that is larger than adiameter of the inlet port and a diameter of the aerosol port.
 82. Thesystem of claim 1, comprising a recirculation tube adapted to return therain-out to the nebulizer.